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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs.

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The GLP-1 Gold Rush: Why Compounded Alternatives Are a Risky Bet

Pharmaceutical Commerce

Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. This all leads to an increased risk of adverse events, like contamination, incorrect dosages, or unexpected side effects, simply because production can vary wildly. References 1.

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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. In the second category—limiting blockades to marketing—are efforts to limit blocking exclusivities and induced infringement liability.

Labelling 104
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Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law Blog: Biosimilars

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.